FindTrial
Sign In

Study comparing two different techniques of surfactant administration in preterm babies with respiratory distress syndrome

Comparison of Less invasive surfactant administration and InSurE method on total duration of respiratory support in babies 26 to 34 weeks of gestation with RDS -An open label randomized control trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/05/025360
Enrollment
200
Registered
2020-05-26
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: P220- Respiratory distress syndrome of newborn

Interventions

Intervention1: LISA: Neonates randomized to LISA group will receive surfactant by orogastric feeding tube. A orogastric feeding tube will be prepared according to desired depth beyond vocal cords. ba

Sponsors

Department of Neonatology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All criteria to be full filled- -Inborn preterm infant 26 weeks to 34 weeks of gestational age -Infants with typical sign and symptoms of RDS -Infants require nCPAP treatment with required fraction of inspired oxygen (FiO2)-0.4 or more in first 6 hours of life.

Exclusion criteria

Exclusion criteria: Anyone of the following- -Infants with major congenital anomalies. -Severe birth asphyxia, Apgar score -Required intubation in birthing area prior to first surfactant dose -Shock prior to randomization -No parental consent

Design outcomes

Primary

MeasureTime frame
-Total duration of respiratory support in hoursTimepoint: till discharge or death—

Secondary

MeasureTime frame
1.BPD 2.Time to regain birth weight 3.Duration of hospitalization 4.Any IVH 5.IVH Papille grade III or IV 6.PDA requiring medical or surgical therapy 7.Any NEC 8.NEC modified BellS stage -2 or above 9.Any R.O.P 10.R.O.P. requiring treatment 11.Repeated surfactant therapy 12.Rates of Air Leaks 13.CPAP failure 14.Death Timepoint: till discharge or death—

Countries

India

Contacts

Public ContactSushma Nangia

Lady Hardinge Medical College

drsnangia@gmail.com9810838181

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 10, 2026